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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSENSITITRE
Generic NameSYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
Regulation Number866.1645
ApplicantTREK DIAGNOSTIC SYSTEMS, INC.
210 BUSINESS PARK DR.
SUN PRAIRIE, WI 53590
PMA NumberN50531
Supplement NumberS004
Date Received01/30/1981
Decision Date04/14/1981
Reclassified Date 09/13/2002
Product Code LON 
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
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